The product is a Real-Time PCR qualitative test for the detection of nucleic acid from SARSCoV-2 in anterior nasal and mid-turbinate nasal swabs, nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirates or nasal aspirates and bronchoalveolar lavage (BAL) specimens from individuals who are suspected of COVID-19 by their healthcare provider. The SARS-CoV2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. To use the product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from anterior nasal and mid-turbinate nasal swabs, nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirates or nasal aspirates or bronchoalveolar lavage (BAL) specimens.
Diagnovital SARS-CoV-2 Real-Time PCR Kit is a Real-Time Qualitative RT-PCR-based test used for the detection of SARS-CoV-2 intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens from individuals suspected of COVID-19 by their healthcare provider. The test is based on conventional RT-PCR technology including extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection.
Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers and probes specific to the SARS-CoV-2 envelope gene (E-gene) and the polymerase gene (RdRP). The RdRP gene target is detected by one probe, unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene was chosen also for the pan-Sarbecovirus detection. The pan-Sarbecovirus detection sets will also detect SARS-CoV-2 virus.
Selective amplification of Internal Control is achieved by the use of non-competitive, sequence specific forward and reverse primers and a probe for the endogeneous human RNAseP gene which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.
Diagnovital SARS-CoV-2 Real-Time PCR Kit has been validated for use with RTA Viral Nucleic Acid Isolation Kit or RTA Viral RNA Isolation Kit for its best performance.
Diagnovital Real Time PCR Kits are certified and marked with CE-IVD to meet specific quality and purity requirements of in-vitro diagnostic use.
The kit follows CDC’s and WHO’s latest detection guidelines (04/2020).
|Target Region||E gene, RdRP gene|
|Sample Type||Human respiratory samples (nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage)|
|Extraction Control||RNAseP gene|
COVID-19 Rapid Test Kit is a qualitative lateral flow immunochromatographic assay for the detection of IgM and IgG antibodies to SARS-CoV-2 in human whole blood, serum or plasma samples. The cassette contains antigens from SARS-CoV-2 / COVID-19 conjugated to gold nanoparticles, which are collected by antibodies in the sample. Antibodies against human IgM and IgG are coated in their respective regions on a nitrocellulose membrane, where they create a coloured line due to the gold nanoparticles. A control region on the upper end of the cassette confirms if the test has been successful.
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